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Should traditional medicines carry ‘not actual science’ disclaimers?

If someone offers to moisten dryness in your triple burner, or soften hardness, or even replenish the gate of vitality, you may wonder exactly what they mean, and ask for their qualifications.

But these are among the unscientific claims complementary medicines are allowed to make under legislation that came into force in March.

Sceptics say this is allowing companies to sell “pseudoscience” to unsuspecting consumers who have trusted the regulator to weed out phoney products.

Other permitted claims include “tonify kidney”, “harmonise middle burner”, “disinhibit water”, “enrich kidney Jing”, “open body orifices” and “extinguish damp-cold”.

The vast majority of the more than 1000 permitted indications are not required to be backed up with scientific evidence. Instead, they can rely on “traditional use”.

To prove traditional use, you just have to show the ingredient has been used for more than 75 years in an alternative medical tradition, like Western herbalism or homeopathy.

On top of this, “traditional use” medicines do not have to qualify their advertised claims as not based on scientific evidence or independent testing.

Since the Therapeutic Goods Administration (TGA) released the draft list of permitted indications in July last year, stakeholders and consumer groups have been waging a campaign against what they have called “voodoo medicines that only benefit the company selling them”.

This has now come to a head with Labor announcing it has amended its position on complementary medicines. It now wants traditional medicines to carry disclaimers saying their claims are not based on scientific evidence and have not been independently tested.

How did we get here?

The 2015 Sansom review of medicines regulation specifically looked at this issue of products overstating their therapeutic benefits.

This is particularly relevant to complementary medicines, which are considered lower risk than other medicines, and come under a different regulatory scheme. They must be registered with the TGA, but they do not have to be tested by the TGA.

How do you know which is which? If it says AUST L on the label, it’s a listed medicine. If it’s AUST R, it’s registered, meaning it’s been tested and approved by the TGA.

That distinction is not always clear to consumers, who then would not necessarily know if the product they’re buying has been tested by the regulator.

At the time, the descriptions that companies could put on their AUST L products was unlimited.

The review recommended this should be dialed back: companies must choose from a list of pre-approved claims, to avoid companies making outlandish claims.

It also recommended a disclaimer to inform consumers the effectiveness of the product has not been independently tested, and/or is based on traditional use.

The Government accepted the first recommendation, but not the second. It said it supported the “intention” of the disclaimer idea, and directed the TGA to look into the idea of companies posting an “educative statement” on their websites.

“In accordance with the Government’s commitment to red tape reduction, the Government will not require sponsors to place a disclaimer on product labels,” it said.

Most permitted indications are not backed by science: CHOICE

The TGA, which is entirely funded by industry fees, consulted industry and consumers about what should be included on the list of permitted indications.

It released a draft version of the list in July, and then implemented a revised final version on March 6 this year, after more public and industry consultation.

The TGA says this final version of the list is a lot shorter than the draft – that what companies can claim has been “significantly reduced”.

Despite this, the final list still has more than 1000 permitted indications, including “soften hardness” and the others listed above. According to the consumer rights group CHOICE, 86 per cent of these permitted indications are not backed by scientific evidence.

It’s been running a campaign for “honest labelling” since July last year.

It’s now celebrating what it says is a “consumer win on unproven supplements”.

“Labor’s decision … to strengthen consumer protections on traditional medicines is a huge win for consumers,” says CHOICE’s Katinka Day.

“Clear and prominent disclaimers on products with no scientific basis will enable consumers to separate fact from fiction and ensure they don’t pay for products that may not work.”

The TGA says it will continue to consult with medical experts about the most appropriate words that should be used for permitted indications.

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